RESEARCH - Clinical efficacy and safety of Orencia in MTX-naive patients with early RA and poor prognostic factors

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Ann Rheum Dis. Published Online First: 5 January 2009.

doi:10.1136/ard.2008.101121

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Extended Report

Clinical efficacy and safety of abatacept in methotrexate-naïve

patients with early rheumatoid arthritis and poor prognostic factors

Rene Westhovens 1*, Robles 2, Ximenes 3,

Savithree Nayiager 4, Jurgen Wollenhaupt 5, Durez 6,

Gomez-Reino 7, Walter Grassi 8, Boulous Haraoui 9, Shergy 10,

Sung-Hwan Park 11, Harry Genant 12, fy 13, Jean-Claude

Becker 14, Covucci 14, Roy Helfrick 14 and Joan Bathon 15

1 UZ Gasthuisberg, Belgium

2 Centro Médico Toluca, Mexico

3 Hospital Geral de Goiânia, Brazil

4 St Augustine's Hospital, South Africa

5 Klinikum Eilbek, Germany

6 Cliniques Universitaires Saint-Luc, Belgium

7 7Hospital Clinico Universidad De Santiago, Spain

8 Clinica Reumatologica, Italy

9 Institut de Rheumatologie de Montréal, Canada

10 University of Alabama, United States

11 The Catholic University of Korea, Korea, Republic of

12 University of California, United States

13 Synarc, Inc., United States

14 Bristol-Myers Squibb, United States

15 Hopkins University, United States

Abstract

Objectives: To assess the efficacy and safety of abatacept in

methotrexate (MTX)-naïve patients with early rheumatoid arthritis (RA)

and poor prognostic factors.

Methods: In this double-blind, Phase IIIb study, patients with RA 2

years were randomized 1:1 to receive abatacept (~10 mg/kg) plus MTX,

or placebo plus MTX. Patients were MTX-naïve and seropositive for

rheumatoid factor (RF), anti-cyclic citrullinated protein (CCP) 2 or

both, and had radiographic evidence of joint erosions. The co-primary

endpoints were the proportion of patients achieving Disease Activity

Score (DAS) 28-defined remission (C-reactive protein) and joint damage

progression (Genant-modified Sharp total score [TS]) at Year 1. Safety

was monitored throughout.

Results: At baseline, patients had a mean DAS28 of 6.3, a mean TS of

7.1 and mean disease duration of 6.5 months; 96.5 and 89.0% of

patients were RF or anti-CCP2 seropositive, respectively. At Year 1, a

significantly greater proportion of abatacept plus MTX-treated

patients achieved remission (41.4 vs 23.3%; p<0.001), and there was

significantly less radiographic progression (mean change in TS; 0.63

vs 1.06; p=0.040), versus MTX alone. Over 1 year, the frequency of

adverse events (AEs; 84.8 vs 83.4%), serious AEs (7.8 vs 7.9%),

serious infections (2.0 vs 2.0%), autoimmune disorders (2.3 vs 2.0%)

and malignancies (0.4 vs 0%) was comparable for abatacept plus MTX

versus MTX alone.

Conclusions: In a MTX-naïve population with early RA and poor

prognostic factors, the combination of abatacept and MTX provided

significantly better clinical and radiographic efficacy compared with

MTX alone, and had a comparable, favorable safety profile.

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http://ard.bmj.com/cgi/content/abstract/ard.2008.101121v1?papetoc

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